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IRT Neonatal Luminescence Immunoassay

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325008113
Basic UDI-DI: B-04049325008113
Reference: RE68015
EMDN: W0102019007
EMDN description: IMMUNO REACTIVE TRYPSIN
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:11

Manufacturer products View details

IRT Neonatal Luminescence Immunoassay

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325007666
Basic UDI-DI: B-04049325007666
Reference: RE68019
EMDN: W0102019007
EMDN description: IMMUNO REACTIVE TRYPSIN
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:10

Manufacturer products View details

Procise FCP Assay

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: BIOSYNEX
Manufacturer SRN: FR-MF-000014073
UDI-DI: 03532678603544
Basic UDI-DI: B-03532678603544
Reference: 4664_B
EMDN: W0102019009
EMDN description: CALPROTECTIN
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:47

Manufacturer products View details

D-02B0024YP

Serum amyloid A Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0024YP
Basic UDI-DI: B-02B0024YP
Reference: 3H001
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

D-020005KP

N/A

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIALAB Produktion und Vertrieb von chemisch-technischen Produkten und Laborinstrumenten Gesellschaft m.b.H.
Manufacturer SRN: AT-MF-000000254
UDI-DI: D-020005KP
Basic UDI-DI: B-020005KP
Reference: 020005
EMDN: W0102019001
EMDN description: A1-ACID GLYCOPROTEIN (OROSOMUCOID)
First on market country: Austria
Authorised representative: -
Last updated: 05.07.2026 16:11

Manufacturer products View details

REDI-Dx

Radiation Biodosimetry Test (REDI-Dx Test System)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: DxTerity Diagnostics Inc.
Manufacturer SRN: US-MF-000029372
UDI-DI: 00850521006032
Basic UDI-DI: B-00850521006032
Reference: 135488
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Netherlands
Authorised representative: MedEnvoy Global BV
Last updated: 05.07.2026 11:09

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Cystatin C Control

Cystatin C Control

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021617
Basic UDI-DI: B-00816426021617
Reference: K200C-2M
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Cystatin C Calibrator

Cystatin C Calibrator

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021600
Basic UDI-DI: B-00816426021600
Reference: KAI-200C
EMDN: W0102019008
EMDN description: CYSTATIN C
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY KL-6 Calibrator (Ver.2)

KL-6 Calibrator (Ver.2)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021570
Basic UDI-DI: B-00816426021570
Reference: KAI-351C
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY KL-6 (Ver.2)

KL-6 (Ver.2) Reagent

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021563
Basic UDI-DI: B-00816426021563
Reference: KAI-350
EMDN: W0102019099
EMDN description: SPECIFIC PROTEINS - OTHER
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY Cystatin C Control

Cystatin C Control